CERTA DOSE EPINEPHRINE CONVENIENCE KIT- epinephrine convenience kit kit

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)

Dostępny od:

CD Acquisitions, LLC

Droga podania:

SUBCUTANEOUS

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Adrenalin® is available as a single-use 1 mL vial for intramuscular and subcutaneous use. Emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from allergic reactions to insect stings, biting insects, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. The signs and symptoms associated with anaphylaxis include flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with hypotension, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, airway swelling, laryngospasm, bronchospasm, pruritus, urticaria or angioedema, swelling of the eyelids, lips, and tongue. None. 8.1 Pregnancy Teratogenic Effects: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Epinephrine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus (fetal anoxia, spontaneous abortion, or both). Epinephrine is teratogenic in rabbits, mice and hamsters dosed during organogenesis. Epinephrine has been shown to have teratogenic effects (including gastroschisis and embryonic lethality) when administered subcutaneous in rabbits at approximately 15 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m2 basis at a maternal subcutaneous dose of 1.2 mg/kg/day for two to three days). In mice, teratogenic effects (including embryonic lethality) were observed at approximately 3 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m2 basis at maternal subcutaneous dose of 1 mg/kg/day for 10 days). These effects were not seen in mice at approximately 2 times the maximum recommended daily intramuscular or subcutaneous dose (on a mg/m2 basis at a subcutaneous maternal dose of 0.5 mg/kg/day for 10 days). In hamsters, teratogenic effects were observed at approximately 2 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day for 4 days). 8.2 Labor and Delivery Use with caution during labor and delivery. Although epinephrine improves maternal hypotension associated with anaphylaxis, it may result in uterine vasoconstriction, decreased uterine blood flow, and fetal anoxia. 8.3 Nursing Mothers It is not known whether epinephrine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when epinephrine is administered to a nursing woman. 8.4 Pediatric Use Clinical use data support weight-based dosing for treatment of anaphylaxis in pediatric patients, and other reported clinical experience with the use of epinephrine suggests that the adverse reactions seen in children are similar in nature and extent to those both expected and reported in adults. 8.5 Geriatric Use Clinical studies for the treatment of anaphylaxis have not been performed in subjects aged 65 and over to determine whether they respond differently from younger subjects. However, other reported clinical experience with use of epinephrine for the treatment of anaphylaxis has identified that geriatric patients may be particularly sensitive to the effects of epinephrine. Therefore, for the treatment of anaphylaxis, consider starting with a lower dose to take into account potential concomitant disease or other drug therapy.

Podsumowanie produktu:

Certa Dose Epinephrine Kit (NDC 71754-001-01) KIT CONTENTS Epinephrine 1 mg/mL Vial (1 mL) 2 x CERTA DOSE* 0.3 mL Syringe, Permanent Needle, 29 G x ½” Epinephrine Package Insert IFU CERTA DOSE* 0.3 mL Syringe Par Adrenalin (1 Vial, NDC 42023-159-25) included in Certa Dose Epinephrine Kit 1 mL Adrenalin® (epinephrine injection, USP) solution 1 mg/mL in a 3 mL clear glass vial. NDC 42023-159-25 1 mL vial Certa Dose Epinephrine Kit (NDC 71754-001-05) KIT CONTENTS 5 Vials - Epinephrine 1 mg/mL (1 mL) 5 x CERTA DOSE* 0.3 mL Syringe, Permanent Needle, 29 G x ½” Epinephrine Package Insert IFU CERTA DOSE* 0.3 mL Syringe Par Adrenalin (1 Vial, NDC 42023-159-25) included in Certa Dose Epinephrine Kit 1 mL Adrenalin® (epinephrine injection, USP) solution 1 mg/mL in a 3 mL clear glass vial. NDC 42023-159-25 1 mL vial Vial and contents must be discarded 30 days after initial use. Store between 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Epinephrine is light sensitive. Protect from light and freezing. Inspect visually for particulate matter and discoloration prior to administration. Do not use the solution if it is colored or cloudy, or if it contains particulate matter.

Status autoryzacji:

New Drug Application

Charakterystyka produktu

CERTA DOSE EPINEPHRINE CONVENIENCE KIT- EPINEPHRINE CONVENIENCE KIT
CD ACQUISITIONS, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
EPINEPHRINE CONVENIENCE KIT
NDC 71754-001
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE THE
EPINEPRHINE
CONVENIENCE KIT SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR EPINEPHRINE. INITIAL U.S.
APPROVAL; 2012
INDICATIONS AND USAGE
Adrenalin® is a non-selective alpha and beta adrenergic agonist
indicated for: (1)
Emergency treatment of allergic reactions (Type 1), including
anaphylaxis as well as idiopathic anaphylaxis
or exercise-induced anaphylaxis. (1)
DOSAGE AND ADMINISTRATION
Anaphylaxis
Adults and Children 30 kg (66 lbs) or more: 0.3 to 0.5 mg (0.3 to 0.5
mL) intramuscularly or
subcutaneously into anterolateral aspect of the thigh every 5 to 10
minutes as necessary (2)
Children 30 kg (66 lbs) or less: 0.01 mg/kg (0.01 mL/kg), up to 0.3 mg
(0.3 mL), intramuscularly or
subcutaneously into anterolateral aspect of the thigh every 5 to 10
minutes as necessary (2)
DOSAGE FORMS AND STRENGTHS
Injection: 1 mg/mL, 1 mL single-use vials (3)
CONTRAINDICATIONS
None (4) (4)
WARNINGS AND PRECAUTIONS
Do not inject into buttocks, digits, hands, or feet (5.1)
Rare cases of serious skin and soft tissue infections have been
reported following epinephrine injection.
Advise patients to seek medical care if they develop signs or symptoms
of infection. (5.2)
May aggravate angina pectoris or produce ventricular arrhythmias,
particularly in patients with
underlying heart disease, administer with caution when used
intramuscularly or subcutaneously (5.3)
Patients with hyperthyroidism, Parkinson’s disease, diabetes, and
pheochromocytoma are at greater
risk of having adverse reactions when used intramuscularly or
subcutaneously (5.3)
Presence of sulfite in this product should not deter use for
anaphylaxis (5.4)
ADVERSE REACTIONS
Common adverse reactions to systemically administered epinephrine
include anxiety, apprehensiveness,
restlessness, tremor, weakness, dizzine